Recommendations on ELISpot assay validation by the GCC.
Bioanalysis
; 14(4): 187-193, 2022 Feb.
Article
em En
| MEDLINE
| ID: mdl-35135309
ABSTRACT
Gene therapy, cell therapy and vaccine research have led to an increased need to perform cellular immunity testing in a regulated environment to ensure the safety and efficacy of these treatments. The most common method for the measurement of cellular immunity has been Enzyme-Linked Immunospot assays. However, there is a lack of regulatory guidance available discussing the recommendations for developing and validating these types of assays. Hence, the Global CRO Council has issued this white paper to provide a consensus on the different validation parameters required to support Enzyme-Linked Immunospot assays and a harmonized and consistent approach to Enzyme-Linked Immunospot validation among contract research organizations.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Bioensaio
/
Terapia Genética
/
ELISPOT
/
Terapia Baseada em Transplante de Células e Tecidos
Tipo de estudo:
Guideline
Limite:
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article